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Effectiveness and safety of novel oral anticoagulants compared with vitamin K-antagonists in the treatment of acute symptomatic venous thromboembolism- a systematic review and meta-analysis.
J Thromb Haemost. 2013 Dec 13;
Authors: van der Hulle T, Kooiman J, den Exter PL, Dekkers OM, Klok FA, Huisman MV
Abstract
INTRODUCTION: New direct oral anticoagulants (NOACs) are a novel treatment option for acute venous thromboembolism (VTE) with practical advantages. Individual studies demonstrated comparable efficacy and suggest a more favourable safety profile compared with vitamin K-antagonists (VKA). We performed a meta-analysis to determine the efficacy and safety profile of NOACs compared with VKA in patients with acute VTE.
METHODS: We searched Medline, Embase, the Cochrane Database of Systematic Reviews, and the Clinical Trials Registry until October 2013. Eligible studies included phase-three trials comparing NOACs to VKA in patients with acute VTE. Risk ratios (RR), absolute risk differences and numbers needed to treat (NNT) to prevent one event were calculated for recurrent VTE, fatal pulmonary embolism (PE), overall mortality, major bleeding, and other bleeding complications using random effects models.
RESULTS: Five studies were included investigating four NOACs (rivaroxaban, dabigatran, apixaban and edoxaban) in 24,455 patients with acute VTE. RR for recurrent VTE, fatal PE and overall mortality for NOACs versus VKA were 0.88 (95%CI 0.74-1.05), 1.02 (95%CI 0.39-5.96) and 0.97 (95%CI 0.83-1.14), respectively. The RR of major bleeding was 0.60 (95%CI 0.41-0.88). NNT with NOACs instead of VKA to prevent one major bleeding was 149. The RR and NNT for fatal bleeding were 0.36 (95%CI 0.15-0.87) and 1,111. A fixed effect network analysis did not demonstrate significant differences between individual NOACs compared to rivaroxaban.
CONCLUSIONS: NOACs have a comparable efficacy and are associated with a significantly lower risk of bleeding complications, although the NNT to prevent one major bleeding was relatively high. This article is protected by copyright. All rights reserved.
PMID: 24330006 [PubMed - as supplied by publisher]